Zander Nicole, Demirel Ebru-Berrin, Augustin Matthias, Sommer Rachel, Debus Eike Sebastian, Breuer Peter, Blome Christine
1 Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
2 Department of Vascular Medicine, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Vasa. 2018 Apr;47(3):219-226. doi: 10.1024/0301-1526/a000687. Epub 2018 Jan 25.
The aim of this study was to develop and validate a specific Patient Benefit Index (PBI) version for the treatment of peripheral arterial disease (PAD).
A non-interventional longitudinal development study was conducted. The first phase comprised a qualitative pre-study with n = 50 patients, in which the PBI was adapted for peripheral arterial disease. The resulting Patient Benefit Index for peripheral arterial disease (PBI-PAD) was validated in the second phase at two points of measurement. The total PBI-PAD score was calculated by weighting item-wise the achievement of treatment goals with the initially assessed needs. Feasibility, internal consistency, and construct validity were analysed and the generic three level version of the EuroQol five-dimensional questionnaire (EQ-5D-3L) and the disease-specific instrument Vascular Quality of Life Questionnaire (VascuQoL) were used for convergent validation.
In the pre-study, the PBI-PAD, consisting of 12 items, was developed. N = 103 patients participated in the main study. At T2, data were available for n = 57 patients. Mean age was 71.0 years ± 9.1 and 66.7 % of the participants were male. The amount of missing values of the PBI-PAD score was low (< 4.0 %) and no relevant floor effects were observed. Both parts of the PBI (needs at T1 and benefits at T2) were internally consistent with Cronbach’s alpha > 0.7. PBI-PAD total score correlated significantly with the T2-T1-differences of the EuroQol-visual analogue scale (EQ VAS) (r = 0.4, p = 0.007) and the Vascular Quality of Life Questionnaire (r = 0.5, p < 0.001).
The PBI-PAD is a feasible, internally consistent, and valid instrument to assess patient-relevant benefits in PAD patients receiving minimally invasive treatment or surgical procedures. It can be recommended for use in routine care as well as in clinical studies.
本研究的目的是开发并验证用于治疗外周动脉疾病（PAD）的特定患者获益指数（PBI）版本。
开展了一项非干预性纵向开发研究。第一阶段包括对n = 50名患者进行的定性预研究，在此研究中对PBI进行了外周动脉疾病适应性调整。在外周动脉疾病患者获益指数（PBI-PAD）在第二阶段的两个测量点进行了验证。PBI-PAD总分通过将治疗目标的达成情况按项目权重与最初评估的需求相乘来计算。分析了可行性、内部一致性和结构效度，并使用欧洲五维健康量表通用三级版本（EQ-5D-3L）和疾病特异性工具血管生活质量问卷（VascuQoL）进行收敛效度验证。
在预研究中，开发了由12个项目组成的PBI-PAD。n = 103名患者参与了主要研究。在T2时，有n = 57名患者的数据可用。平均年龄为71.0岁±9.1岁，66.7%的参与者为男性。PBI-PAD得分的缺失值数量较低（<4.0%），未观察到相关的地板效应。PBI的两个部分（T1时的需求和T2时的获益）内部一致性良好，Cronbach's α>0.7。PBI-PAD总分与欧洲五维健康量表视觉模拟量表（EQ VAS）的T2 - T1差值（r = 0.4，p = 0.007）以及血管生活质量问卷（r = 0.5，p < 0.001）显著相关。
PBI-PAD是一种可行、内部一致且有效的工具，可用于评估接受微创治疗或外科手术的PAD患者的患者相关获益。推荐其用于常规护理以及临床研究。
